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A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus and Minus Traztuzumab (TC ± H) in the Treatment of Breast Cancer

Trial Information

A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus and Minus Traztuzumab (TC ± H) in the Treatment of Breast Cancer

Inclusion Criteria:

- Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory (see Section 10.1a) breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.

- Patients must meet one of the criteria defined below (indicate one):

- Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.

- Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a MUGA or echocardiogram scan performed within 90 days prior to registration (indicate NA if no MUGA required) and LVEF% must be greater than the institutional lower limit of normal.

- Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an SGOT or SGPT ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.

- Patients must have an ANC of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to registration.

- Patients must have a performance status of 0-2 by Zubrod criteria

- Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.

- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

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